Identity
- Device Name
- Sterilization Pouch EUDAMED
- Model / Reference
- S01010101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975803830007 EUDAMED
- Basic UDI-DI
- 697580383HC0SP001YT EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterilization Pouch by Hefei Hanchin Medical Supplies Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697580383HC0SP001YT | Class I | Active |
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Manufacturer
- Manufacturer
- Hefei Hanchin Medical Supplies Co., Ltd
- EUDAMED SRN
- CN-MF-000030468
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED ac4c5c40-cc17-4238-a7e2-4de33267695e 61 fields · synced Jul 9, 2026